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68 Cards in this Set
- Front
- Back
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How much does the cost of clinical trials account for in percent? |
80% to 90% |
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Pharmacology |
Studies on how drug impacts the body and how the body interacts with the drug |
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Carcinogenicity |
Identify cancer-inducting potential |
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Genotoxicitiy |
Detect the drugs ability to cause an increase in genetic alterations |
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How many stages are required before approval? |
4 Stages |
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How many drugs who make it to clinical make it to the market? |
1 in 5 |
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Which phase do drugs normally fall in? |
Phase 2 |
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Phase 4 of Clinical Trials |
Safety and Efficacy Designed to detect any rare or long term adverse effects |
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Phase 3 of Clinical Trials |
Random and Controlled See how effective it is compared to the "gold standard" Costs the most money in this phase |
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Phase 2 of Clinical Trials |
Efficacy= Capacity for having a beneficial change or therapeutic effect Large number of people Usually a drug will fail here "Not work as planned" or Toxic effects |
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Phase 1 of Clinical Trials |
Focus on safety Healthy individuals Small number of people Figuring out dose ranging |
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What phase is it marketed? |
After phase 3 |
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What happens if you violate FDA? |
Inspections and investigations Warning letters Recall Withholding Suspense Clivil Lawsuit Prosecution |
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Adulteration |
Something that is not supposed to be there |
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Roles of the FDA |
Regulate drugs&tests&biologics&labeling and post market surveillance |
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Misbranding |
Something wrong with how it is labeled not correct |
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Mission of the FDA |
To promote and protect Ensure that food and medical products are safe and effective Does not dictate medical practice or service
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What role can plant biotechnology play in the world (applications) |
Protect crops from disease Increase the yield of food crops Reduce the need for pesticides Improve nutritional value of food Make plant based medicines and vaccines Provide a source for better and more sustainable biofuels Help to protect the environment |
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What is considered natural and what is considered GM with regards to food? |
Genetically modified (GM) foods are foods derived from organisms whose genetic material (DNA) has been modified in a way that does not occur naturally Natural are foods that aren't altered in anyway shape or form |
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Which breeding methods are considered natural and can be labeled “natural” and which would be GM (unnatural) |
GM breeding methods: gene splicing, agrobacterium tumefaciens, gene guns, antisense technology Natural food breeding methods: Selective Breeding, Hybridization, Grafting, Mutation Breeding |
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Genetically modified? |
The use of modern biotechnology techniques to change the DNA of an organism, such as a plant or animal |
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Transgenic Organisms? |
An organism that has a gene from another species inserted into their genome |
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Recombinant Technology? |
Involves inserting a gene from one organism into another though the use of a cloning vector |
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Recombinant DNA molecule? |
The result of ligase is added to "glue" the sugar phosphate backbone together and seal the DNA fragments together
Such as a plasmid carrying the gene of interest |
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Why can transgenic organisms be useful to society? |
Drugs Food/Animals Industrial Applications Environmental Applications Gene Therapy and Disease Research
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Cloning Vector? |
What you attach your gene to for transfer into the other organisms, plasmid is the most common. Bacterphages are another type they are modified so that they transport DNA but don't cause disease. Stemcell, Viruses and Bacterial artificial chromosomes and also be vectors |
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Characteristics of all stem cells that make them useful to doctors and researchers |
They are pluripotent meaning that they can form any cell type (except placetra) Over 220 possible cell types |
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What does undifferentiated mean? |
Biological cells that can differentiate into specialized cells and can divide (through mitosis) to produce more stem cells. They are found in multicellular organisms. |
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What are the three kinds of stem cells? |
Embryonic Stem Cells: Come from a five to six-day-old embryo. They have the potential to form virtually any type of cell found in the human body Adult Stem Cells iPS cells |
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What are pluripotent, Multipotent, Totipotent? |
Pluripotent: cells that can form into any cell type expect placetra Multipotent: More differentiated cells, but can form a number of different cell types within a cell line Totipotent: They have the potential to develop into any cell found in the human body form a zygote |
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What are the myths and facts? |
Myths: Removing a mothers fetus from her There are body parts on the embryo recognizing them as humans It is illegal Fact: Never taken from the women's body and are created in the lab They are blastocysts and nothing is recognizable No option on either for or against by the government |
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Embryonic stem cell debate |
Removing the embryonic stem cells from the blastocyst destroys the embryo Destroying a living person because this blastocyst could potentially grow Science is going to far |
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Advantages and Disadvantages of embryonic stem cells? |
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iPS cells? |
Cells created from adult cells or adult cells that are reverted back to be embryonic like undifferentiated |
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Does the creation of iPS cells destroy an embryo? |
no |
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Advances and Disadvantages of working with iPS cells? |
Advantages: Does not destroy or create Same potential as embryonic stem cells Less tissue rejection potentint since cells are from the patient's own body Disadvantages: Very little is known needed stem cell research same epigenetics patterns? there is the potential for rejection |
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What are adult stem cells? Where are they found in the body? |
Typically found among specialized or differentiated cells in a tissue or organ. They are more differentiated than Embryonic |
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Advantages and disadvantages of Adult Stem Cells? |
Advantages: Match the patient's own cells Lack of converse Most research Disadvantages: Exist in small numbers Difficult to identify, isolatem purify and grow in the lab |
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Where are embryonic stem cells taken from? |
early stage embryos called blastocyst |
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what is most important about a proteins ability to perform it's function? |
Shape |
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What is the purpose of performing protein electrophoresis? (SDS-PAGE) |
Determining the proteins before putting them into the gel How many proteins are in my sample? Molecular weight of the proteins? Differences? How pure is the sample? How much protein? |
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What causes the proteins to move differently in the gel? |
The amount of DNA |
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Why do we have to use a different gel? |
The pores are way smaller in size |
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What does it mean when a gene is expressed or on? |
It means that it is showing |
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How do genes code for proteins? |
In translation though mRNA |
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What are proteins made up of and what type of bonds hold them together? |
Chains of amino acids and Peptide bond |
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Analogy of how to make a protein |
DNA is the cookbook Ribosomes are the chefs Directions for making the cake (proteins) have to get out of the nucleus and to the ribosomes mRNA has to photocopy the recipe that goes to the cook cook is ribosomes tRNA brings the ingredients (amino acids) to the ribosome |
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What happens to the pre-mRNA before it can leave the cell to go to the ribosome? |
The RNA needs to be modified in several ways 5' end needs to be capped 3' end has a poly A tail Alternate Splicing Occur |
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How many genes do we have that code for how many proteins? |
20,000 genes that code for approximately 100,000 proteins |
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What is splicing? |
Before mRNA exits the nucleus it is cut and introns are removed leaving only exons |
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Alternate splicing? |
A process where eons are removed from the pre mRNA Allows for multiple proteins to be made |
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What direction is DNA read and what direction is it built? |
3'-5' and 5'-3' |
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DNA CODE IS A TRIPLET |
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What is our epigenome? |
is a pattern of the gene expression in a cell |
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What is the difference between our genome and our epigenome? |
Our genome contains all the instructions for building and maintaining the parts of our body Our epigenome is a pattern of the gene expression in a cell |
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Methylation and Acetylation |
Methylation: Attach directly to the gene and usually turn off the gene Acetylation: Loose = turn on tight= turn off |
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Which is fixed and which is environmental |
Genome is fixed epigenome is environmental |
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Can epigenetic patterns be inherited? How? |
Yes some epigenetic tags remain in place as genetic info passes from generation to generation epigenetic inheritance |
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What are some environmental impacts to our epigenome? |
Diet, Toxins, Stress, Physical activity, hormones |
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What does it mean to silence a gene? |
Occurs when a gene is turned off that would normally be expressed under normal conditions |
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What is RNAi and what does it stand for? |
RNA interference and have control over which genes are active and how active they are |
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How could the use of the RNAi system help us treat disease? Which types? |
It will help in immune response, identifying a gene function, medicine and bioengineering and it only helps with gene you need to turn off a gene |
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What triggers the RNAi system? |
long-double stranded molecule |
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Why didn't all the worms experience a knockdown? |
we gave them a protein that was developing so it only affected the kid ones |
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Importance of bioinformatics |
Bioinformatics is an interdisciplinary field that develops and improves on methods for storing, retrieving, organizing and analyzing biological data. A major activity in bioinformatics is to develop software tools to generate useful biological knowledge. |
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Electropherogram? |
is a plot of results from an analysis done by electrophoresis automatic sequencing |
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What is a DNA barcode? What are the lines? |
A unique DNA sequence that identifies each living thing in the same way that the unique pattern of bars in a universal product code identifies each consumer product The lines are your DNA |
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When you BLAST a sequence what are you doing? |
You will identify known sequence in the database |
